Effects Of Food And Dose Regimen On The Antiviral Effects Of Maraviroc (UK-427,857) In Patients With Human Immunodeficiency Virus

HIV Clinical Trial

Official title:

An Investigation Into The Effects Of Food And Dose Regimen On Viral Load Response In HIV Infected Patients On Short-Term Monotherapy With UK-427,857 (Maraviroc)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00634959
• Other study ID #: A4001015
• Status: Completed
• Phase: Phase 2
• First received: March 5, 2008
• Last updated: November 9, 2010
• Start date: July 2003
• Est. completion date: December 2003

Study information

• Verified date: November 2010
• Source: ViiV Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To investigate the effects of food and dose regimen on the antiviral effects of Maraviroc (UK-427,857) in patients with human immunodeficiency virus (HIV)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: December 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Asymptomatic HIV-1 infected male and female patients

• Weight between 50 and 100kg and within the permitted range for their height

• Patients with virus that targets CCR5 receptor

Exclusion Criteria:

• Patients with a CD4 count <250 cells/mm3 or HIV viral load <5000 copies/mL

• Patients whose HIV infection has been diagnosed less than 3 months prior to screening, or for who there is evidence of recent seroconversion

• Patients with acquired immunodeficiency syndrome (AIDS) or a previous AIDS diagnosis

• Patients who are taking or have taken antiretroviral drugs in the eight weeks prior to the study screening visit

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV
• HIV Infections

Intervention

Drug:
• Maraviroc (UK-427,857)
150 mg oral tablet twice daily while fasted on Days 1-9 and on Day 10 (morning dose only)
• Maraviroc (UK-427,857)
100 mg oral tablet once daily while fasted on Days 1-10
• Maraviroc (UK-427,857)
300 mg oral tablet once daily while fasted on Days 1-10
• Maraviroc (UK-427,857)
150 mg oral tablet twice daily with food on Days 1-9 and on Day 10 (morning dose only)

Other:
• Placebo
Matching placebo oral tablet on Days 1-10 (fed and fasted)

Locations

Country	Name	City	State
Germany	Pfizer Investigational Site	Frankfurt
Germany	Pfizer Investigational Site	Hamburg
Germany	Pfizer Investigational Site	Koeln
United Kingdom	Pfizer Investigational Site	London
United Kingdom	Pfizer Investigational Site	London
United States	Pfizer Investigational Site	Birmingham	Alabama
United States	Pfizer Investigational Site	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
ViiV Healthcare	Pfizer

Countries where clinical trial is conducted

United States,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in viral load		Day 11	No
Primary	UK-427,857 pharmacokinetics		Days 1-11	No
Secondary	Physical examination		Days 1, 11, 40	Yes
Secondary	12-lead ECG		Days 1-11 and Day 40	Yes
Secondary	Relationship of change in viral load (baseline to Day 11) versus mean receptor saturation (Day 10)		Days 1-11	No
Secondary	Time course of viral load from baseline to follow-up		Days 1-13 and Days 15, 19, 22, 25, 40	No
Secondary	CCR5 receptor saturation		Days 1, 5, 10, 11, 13, 15, 19, 40	No
Secondary	Adverse events		Days 1-40	Yes
Secondary	Relationship of change in viral load (baseline to Day 11) versus baseline susceptibility (IC50 and IC90)		Days 1-11	No
Secondary	Laboratory safety		Days 1, 3, 7, 11, 15, 40	Yes
Secondary	Relationship of change in viral load (baseline to Day 11) versus average and trough plasma concentrations (Day 10)		Days 1-11	No
Secondary	Supine/standing blood pressure and pulse rate		Days 1-11 and Day 40	Yes
Secondary	Time to rebound of viral load		Days 1-13 and Days 15, 19, 22, 25, 40	No

External Links

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